Evaluating a new theranostic approach for pancreatic cancer
First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer
This study is testing a new treatment for pancreatic cancer to see if a special imaging method can help find the right patients for a targeted therapy that might improve their outcomes.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT04665947 on ClinicalTrials.gov |
What this trial studies
This Phase I, first-in-human study aims to assess the safety and efficacy of the theranostic pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in patients with locally advanced or metastatic pancreatic adenocarcinoma. The study will utilize PET imaging with [68Ga]Ga DOTA-5G to identify eligible patients for treatment with [177Lu]Lu DOTA-ABM-5G. The primary objectives include determining the dose limiting toxicity and the recommended phase 2 dose of [177Lu]Lu DOTA-ABM-5G. An expansion group will also be included to gather initial response estimates and further safety information.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with confirmed locally advanced or metastatic pancreatic adenocarcinoma who have experienced tumor progression after prior treatment.
Not a fit: Patients with pancreatic cancer types other than adenocarcinoma or those who have not progressed after prior therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new targeted therapy option for patients with advanced pancreatic cancer.
How similar studies have performed: While this approach is novel, similar theranostic strategies have shown promise in other cancers, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \[68Ga\]Ga DOTA-5G PET/CT Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document. 2. Age 18 or more years 3. Confirmed presence of locally advanced, unresectable or metastatic pancreatic adenocarcinoma (other pancreatic malignant histologies are excluded) with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis) 4. Participant must have documented tumor progression during or following at least one prior systemic regimen as established by CT or MRI scan within 28 days of enrollment 5. Eastern Cooperative Oncology Group Performance Status ≤ 2 6. Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to \[68Ga\]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline. 7. Hematologic parameters defined as: 1. Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 2. Platelet count ≥ 100,000/mm3 3. Hemoglobin ≥ 8 g/dL 8. Blood chemistry levels defined as: 1. AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) 2. Total bilirubin ≤ 2 times ULN 3. Creatinine ≤ 2 times ULN 9. Anticipated life expectancy ≥ 3 months 10. Able to remain motionless for up to 30-60 minutes per scan \[177Lu\]Lu DOTA-ABM-5G therapy Inclusion Criteria: 1. Completion of entry into \[68Ga\]Ga DOTA-5G PET study and completion of scan 2. The presence of at least one measurable disease by \[68Ga\]Ga DOTA-5G PET/CT (SUVmax\>2-fold above normal lung or liver) Exclusion Criteria: * \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G therapy Exclusion Criteria: 1. Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA) 2. Participants with Class 3 or 4 NYHA Congestive Heart Failure 3. Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding) 4. Pregnant or lactating women 5. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks 6. Has an additional active malignancy requiring therapy within the past 2 years 7. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy 8. Psychiatric illness/social situations that would interfere with compliance with study requirements 9. Previous radiation therapy for the treatment of advanced or metastatic disease 10. Cannot undergo PET/CT scanning because of weight limits (350 lbs) 11. INR\>1.2; PTT\>5 seconds above UNL
Where this trial is running
Sacramento, California
- University of California Davis — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Julie L Sutcliffe — University of California, Davis
- Study coordinator: Julie L Sutcliffe
- Email: jlsutcliffe@ucdavis.edu
- Phone: 916-734-5536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.